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Table 1 Schedule of enrollment, interventions and assessment time points

From: Youth Early-intervention Study (YES) – group interventions targeting social participation and physical well-being as an adjunct to treatment as usual: study protocol for a randomized controlled trial

Phase

Pre-randomization

Post-randomization

Post-trial

Time point

Enrollment

Allocation

week 1

week 8

week 11

week 19

week 52 follow-up

Enrollment

x

      

Clinical assessment (including DSM-IV diagnosis by treating medical practitioner)

Eligibility screen

x

      

Informed consent

x

      

Randomization

 

x

     

Allocates sequence of modules:

AB or BA

1st Module

  

   

2nd Module

    

 

Primary assessments:

  

x

x

x

x

x

Functioning - SOFAS and FAST

Symptoms - SPHERE12

  

x

x

x

x

x

Disability - BDQ

Self-esteem - RSEQ

Vocational status:

x

    

x

x

Education, employment, receipt of benefits, etc.

Engagement with intervention:

   

x

 

x

 

Number of sessions attended

Secondary assessments:

  

x

x

x

x

x

Levels of distress - K-10

Social well-being - WHOQOL

Physical health/Lifestyle:

  

x

x

x

x

x

Sleep profile - PSQI

Exercise/Activity profile - IPAQ

Tobacco and substance use - ASSIST

Other measures:

x

 

x

x

x

x

x

Anthropometrics:

BMI, body weight, waist circumference

Metabolic screen and other blood tests:

x

    

x

x

Lipids, fasting glucose, FBC, LFTs, etc.

  1. ASSIST Alcohol, Smoking and Substance Involvement Screening Test, BDQ Brief Disability Questionnaire, BMI body mass index, DSM-IV Diagnostic and Statistical Manual of Mental Disorders, version IV, FAST Functional Assessment Short Tool, FBC full blood count, IPAQ International Physical Activity Questionnaire, K-10, Kessler Psychological Distress Scale, LFTs liver function test, PSQI, Pittsburgh Sleep Quality Index, RSEQ Rosenberg Self Esteem Questionnaire, SOFAS Social and Occupational Functioning Assessment Scale, SPHERE 12 Somatic and Psychological Health Report, WHOQOL World Health Organization Quality of Life Scale